Associate Director, Regulatory Affairs at Organon in Kuala Lumpur

Job description

Job Description The Position The Assoc. Director is responsible for all aspects of regulatory and pharmacovigilance responsibilities in Malaysia. Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable new products that are developed, manufactured, or distributed in compliance with the local legislations. This role is responsible for managing post-marketing Lifecycle Management (LCM) activities (e.g. change management, line extension, re-registrations, claims, labeling support) and external regulatory surveillance. This role reports to AP Cluster Regulatory Lead and manages direct reports within the assigned market. She/he will be a member of local leadership team, drives innovation and ensures that product registration strategies, preparation/submission of marketing approval applications are well integrated into the business plans. Responsibilities Develops product registration plans & strategies in accordance with local regulations and global standards, working cross-functionally to review & communicate the registration strategy with management oversight. Identifies and manages risks and business needs. Supports development and implementation of leading-edge systems and simplify practices internally/ across functions. Identify and implement new regulatory policies, SOPs, as appropriate. Provides regulatory expertise in the planning, execution, and maintenance of major projects that have high impact to the business. Represents RA in cross-functional organizational and alliance partner forums, support due diligence activities and execute respective agreements as needed. Serves as local Subject Matter Expert on relevant regulatory processes. Participate on local company committees and councils (as appropriate) for matters impacting regulatory compliance. Drives regulatory compliance and quality, prepares for audits/inspections for the assigned market(s) and actively participates in the audit and/or inspection including audits of contractual partners/vendors as necessary. Liaises with the local business units to keep them apprised of regulatory trends and provide input on strategic decisions (i.e., new clinical trials, product launches, and related activities). Coordinates the filing, storage and archiving of regulatory data and documentation in accordance with company’s policies and local requirements Interacts with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business. Competencies Inspires growth: Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed. Demonstrates advanced skills to drive change and champions development. Delivers with accountability: Aligns strategic priorities to team priorities and team resources and delivers results in accordance with timelines and appropriate regulations. Monitor regulatory trends, drives compliance, and proactively manages and mitigates risks to achieve quality outcomes. Innovates with agility: Encourages diverse thinking and experiments with new ways of working. Makes connections: Ability to work in partnership with others (internally and externally) to accomplish quality goals; leads integrated projects and build effective networks. Communicates with optimism and authenticity: Articulates a compelling shared vision and communicates with empathy. Makes timely and appropriate decisions and to determine when escalation of issues is necessary. Activates belonging: Reinforces diverse representation and consideration in all talent selection and development activities across teams. Required Education, Experience and Skills Minimum of 8 - 10 years of industry experience in pharmacovigilance and/or regulatory affairs. Pharmacist license is required. Supervisory experience in managing people/teams/contractors across mark